BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SYNCHRON SYSTEMS METHAQUALONE REAGENT

    K Number: K955676 · Decision Mar 4, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    15
    Applicant Total
    281
    Review Days
    80

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    Basic Information

    Device Name
    SYNCHRON SYSTEMS METHAQUALONE REAGENT
    K Number
    K955676
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3630
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman Instruments, Inc.
    Date Received
    December 15, 1995
    Decision Date
    March 4, 1996
    Product Code
    KXS
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KXS Radioimmunoassay, Methaqualone

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